The PMH Phase I Consortium, led by Dr. Lillian Siu, is a part of the Robert and Maggie Bras and Family Drug Development Program (DDP) at PMH, the largest new drug development program in Canada and the only centre outside the US to have a contract with the NIH for Early Phase Therapeutic studies. PMH and its research arm Ontario Cancer Institute (OCI), both as part of the University Health Network (UHN), have achieved an international reputation as a global leader in the fight against cancer. The goals of PMH Phase I Consortium include: 1) To design and implement early phase studies that determine the safety and tolerability profiles, pharmacologic and molecular effects, as well as preliminary clinical efficacy of investigational anti-cancer agents; 2) to provide appropriate patient populations access to I investigational anti-cancer agents via participation in clinical trials. The research and health care environment and the patient populations in our consortium are ideal for the conduct of phase I trials. The PMH Consortium has the patient referral base, experience, expertise, personnel, infrastructure, equipment I and facilities to conduct phase I single agent or combination trials, limited phase II trials and/or pilot trials of novel targeted agents. The PMH Phase I Consortium is committed to mount NCI-sponsored clinical trials as our top priority research effort. Our approach in the PMH Phase I Consortium for correlative laboratory studies to evaluate the pharmacokinetic, pharmacodynamic and pharmacogenomic endpoints in phase I trials of new agents, are illustrated using specific examples. The exact set of correlative studies to be performed with a novel agent will depend on the type of agent being evaluated, its molecular mechanism(s) of action, and existent knowledge. Relevance to public health: In phase I trials, new cancer treatments or combinations are tested on humans for the first time and they help determine how a drug should be given, how often it should be given, and how much is safe. Cancer is one of the leading causes of death and suffering worldwide and efforts at controlling and curing cancer continue to be needed. With the growing knowledge of molecular abnormalities that drive the cancer cell, and the emergence of new molecularly targeted agents, the ability to safely and efficiently evaluate these agents is crucial for advancing cancer care.